Performance of Cepheid® Xpert MTB/RIF® and TB Biochip® MDR in two regions of Russia with a high prevalence of drug-resistant tuberculosis

Details

• Alternative Title:
  Eur J Clin Microbiol Infect Dis
• Personal Author:
  Kurbatova, Ekaterina V. ; Kaminski, Dorothy A. ; Erokhin, Vladislav V. ; Volchenkov, Grigory V. ; Andreevskaya, Sofia N. ; Chernousova, Larisa N. ; Demikhova, Olga V. ; Ershova, Julia V. ; Kaunetis, Natalia V. ; Kuznetsova, Tatiana A. ; Larionova, Elena E. ; Smirnova, Tatiana G. ; Somova, Tatiana R. ; Vasilieva, Irina A. ; Vorobieva, Alena V. ; Zolkina, Svetlana S. ; Cegielski, J. Peter
• Description:
  Purpose
  
  To assess the performance of Cepheid® Xpert MTB/RIF® (“Xpert”) and TB Biochip® MDR (“TB-Biochip”).
  
  Methods
  
  Sputum specimens from adults with presumptive tuberculosis (TB) were homogenized and split for (1) direct Xpert and microscopy, and (2) concentration for Xpert, microscopy, culture (Lowenstein-Jensen [LJ] solid media and Mycobacteria Growth Indicator Tube® [MGIT]), indirect drug susceptibility testing (DST) using the absolute concentration method and MGIT, and TB-Biochip.
  
  Results
  
  In total, 109 of 238 (45.8%) specimens were culture-positive for M. tuberculosis complex (MTBC), and of these, 67 isolates were rifampicin resistant (RIF-R) by phenotypic DST, and 64/67 (95.5%) were isoniazid resistant (INH-R). Compared to culture of the same specimen, a single direct Xpert was more sensitive for detecting MTBC (95.3%, 95% confidence interval [CI], 90.0–98.3%) than direct (59.6%, 95% CI, 50.2–68.5%) or concentrated smear (85.3%, 95% CI, 77.7–91.1%) or LJ culture (80.8%, 95% CI, 72.4–87.5%); specificity was 86.0% (95% CI 78.9–91.3%). Compared with MGIT DST, Xpert correctly identified 98.2% (95% CI, 91.5–99.9%) of RIF-R and 95.5% (95% CI, 85.8–99.2%) of RIF-susceptible (RIF-S) specimens. In a subset of 104 specimens, the sensitivity of TB-Biochip for MTBC detection compared to culture was 97.3% (95% CI, 91.0–99.5%); specificity was 78.1% (95% CI, 61.5– 89.9%). TB-Biochip correctly identified 100% (95% CI, 94.2–100%) of RIF-R, 94.7% (95% CI, 76.7–99.7%) of RIF-S, 98.2% (95% CI, 91.4–99.9%) of INH-R, and 78.6% (95% CI, 52.1–94.2%) of INH-S specimens, compared to MGIT DST.
  
  Conclusions
  
  Xpert and Biochip were similar in accuracy for detecting MTBC and RIF resistance compared to conventional culture methods.
  
  
• Keywords:
  Adult Bacteriological Techniques Cepheid® Xpert MTB/RIF® Drug Resistance Humans Microbial Sensitivity Tests Mycobacterium Tuberculosis Prevalence Rapid Diagnosis Reproducibility Of Results Russia Sensitivity And Specificity Sputum Tuberculosis Tuberculosis, Multidrug-Resistant

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• Source:
  Eur J Clin Microbiol Infect Dis. 32(6):735-743
• Pubmed ID:
  23263819
• Pubmed Central ID:
  PMC4596226
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHSUnited States/
• Volume:
  32
• Issue:
  6
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:40aa3dfe2ce9103778a42bd87995ffcc79b37b7b1cb52cda8bcf79d617faf686
• Download URL:
  https://stacks.cdc.gov/view/cdc/34839/cdc_34839_DS1.pdf
• File Type:
  [PDF - 511.98 KB ]